CHMP Issues Positive Recommendation for Juta Pharma's Pegfilgrastim Biosimilar

Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.

The next step for the biosimilar will be to await the European Commission (EC)’s final decision on whether to grant a marketing approval for the biosimilar. If the EC ultimately approves the product, it will grant the company a centralized marketing authorization that will be valid in all 28 EU member states. Norway, Iceland, and Liechtenstein, members of the European Economic Area, will follow with corresponding decisions based on the EC’s decision.

If authorized, Grasustek will be available as a 6 mg solution for injection for the prophylaxis of neutropenia in adults being treated with cytotoxic chemotherapy.

The pegfilgrastim biosimilar was developed by USV, a Mumbai-based biosimilar developer that submitted the application for the biosimilar in December 2017. USV later acquired Juta Pharma, a German drug maker with extensive experience in generic drug products.

The application for the biosimilar included data from phase 1 and phase 3 studies of the biosimilar; the phase 1 study compared the pharmacokinetics and pharmacodynamics of the biosimilar with the reference Neulasta at both a therapeutic dose and a low dose, and the phase 3 study followed 254 patients with breast cancer who were scheduled to undergo chemotherapy.

USV also disclosed that it had begun planning for US phase 1 development, and held relevant meetings with the FDA. The company also received approval to initiate phase 3 studies in India.

If Grasustek is authorized in the European Union, it will join already authorized pegfilgrastim biosimilars Fulphila, Ziextenzo, Udenyca, Pelmeg, and Pelgraz. Additional EU-marketed biosimilars used in the prophylaxis of febrile neutropenia are those referencing filgrastim, and include Zarzio (also sold as Filgrastim Hexal), Accofil, Grastofil, Nivestim, and Ratiograstim (also sold as Tevagrastim).